a&r’s News Digest – We dedicate this month’s issue to Italy’s new Decree on botanicals and the first EU authorized 14.1 health claim for a combination product. Also, meet Infarm, this month’s startup.


Invitation to our a&r Webinar series

We are happy to invite you to our next free webinar!

Innovation in probiotics

Date: 15th of November 2018 (Thursday)
Time: 15:00 – 15:45 CET (30 min talk and 15 min Q&A)

Probiotics no longer target just the immune system and/or gut health. Recent research shows that probiotics and prebiotics as well have a much broader application range. The webinar will focus on innovations in the probiotics space – what are the latest products, and what comes next? This webinar may help you identify opportunities for extending your product portfolio.


Dr. Iris Hardewig is Head of the Consulting & Strategic Innovation team at analyze & realize, supporting clients in the development of natural health products. With her knowledge of the natural health market for more than 10 years, she has expert know-how of market opportunities for herbal products.

Regulatory News

No harmonization on the use of botanical among the BELFRIT States

Italy just published a new Decree which includes a new list of botanicals allowed in food supplements. The Decree also includes guidelines that ensure compliance of botanicals in terms of quality and safety. This Decree will take effect on the 10th December 2018.

The use of botanicals in food supplements among Members States is already a complex business. With this decision from the Italian Ministry of Health, Italy becomes a stand-alone market for some food supplements containing botanicals. This decision might support innovation in this product category, but it will make it more difficult for Italian companies to enter other EU countries with certain botanicals in food supplements. Also, companies that want to bring botanical-containing products as food supplements that do not comply with the provisions of this decree into the Italian market will now have to provide proof of marketability in another EU country, as well as proof that these botanicals are not considered Novel Food according to Regulation (EU) 2015/2283.

The decree also contains guidance on a document each notifier of a herbal supplement has to provide to the Authority upon request. The document should contain data on the identification, preparation and stability of the herbal ingredient.
Outside Italy, food supplement manufacturers may want to follow the plant lists from France or Belgium when considering applying for Mutual Recognition with their products, as this may increase their chances to have their products approved in more EU markets.

EC awards first health claim for a combination product on lowering cholesterol

The European Commission published a draft report on the first authorization for a health claim made on a combination product referring to the reduction of disease risk (14.1 health claim). In 2013, EFSA had already issued a positive opinion on this health claim. Now, 5 years later, the EC Commission finally agrees.

The health claim is related to the combination of artichoke leaf dry extract standardized in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers (OPC) from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin, and inositol hexanicotinate and the reduction of blood LDL-cholesterol concentrations. This claim was submitted by Laboratoire Lescuyer (France) on Limicol®.

Limicol® is now the first food supplement with data protection for a claim relating to the reduction in a risk factor for a disease. As of the European Commission’s final approval, Laboratoire LESCUYER will thus be the only company able to make that health claim for its exclusive and patented formula for 5 years.

The claim conditions are:
“Only for food supplements which provide 600 mg artichoke leaf dry extract with 30-36 mg caffeoylquinic acids, 500 mg red yeast rice with 2 mg monacolin K, 10 mg sugarcane derived policosanols, 20 mg French maritime pine bark extract with 18 mg procyanidolic oligomers (OPC), 30 mg garlic dry extract with 0.25 mg allicin, 30 mg α-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate divided in three daily doses to be consumed with the major meals”

Innovation Corner

As we did in our previous issue, we now introduce to you another inspiring startup company. We believe that there are products as well as ideas developed by creative and innovative startup companies that can be very inspiring and are worth spreading!

INFARM: An in-store urban farming startup

Vertical farming is no longer a next generation technology. Actually, this type of innovative agriculture is becoming more and more common in city areas where the available agricultural space/soil no longer exists or is reduced to a minimum, or in areas where environmental conditions can be challenging such as desert areas.

Vertical farming uses a control environment to produce food. In this farming system, food is produced in a controlled environment where soil, light, water, and nutrients are optimized and resources spared. So, sustainability is another of its flagships.

Berlin-based startup Infarm is a vertical farming company founded in 2013. It develops an “indoor vertical farming” system capable of growing anything from herbs to lettuce and other vegetables. Vertical farming is per se not a new concept, but Infarm takes its business model a bit further. What differentiates them from other startups is their modular approach and go-to-market strategy. They place their urban farming units not in offsite warehouses but in customer-facing city locations, such as supermarkets and restaurant kitchens. The end consumer can then pick and choose their products “fresh” and without further packaging. Also, the supply chain is reduced to a minimum.

NutraBusiness Intel

Ceres Pharma acquires Hungary’s Ceumed

28 September 2018

Keurig Dr Pepper (KDP) reached an agreement to acquire Core Nutrition LLC, a leading bottled water and other drinks maker, at a value of US$ 525 million. KDP is a leading coffee and beverage company in North America. This acquisition is expected to boost Keurig Dr Pepper’s portfolio beyond its coffee and other beverage brands.

Glanbia plc acquires SlimFast 

11 October 2018

Ireland-based company Glanbia plc acquires SlimFast for US$ 350 million to complement its existing portfolio. SlimFast is a leading consumer brand in the weight management nutrition market co-owned by KSF Holdings LLP and HNS Intermediate Corporation.

Novelties in our MatchMaking Platform

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Your experts

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

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